Human and biological samples

The following principles outline UKRI’s expectations when research involves human biological material. These principles underpin all UKRI-funded research (whether supported wholly, or in part, by UKRI).

Key principles

Samples should be treated as donations and research involving samples should be conducted with respect and transparency

The human body and its parts should be treated with respect. Before approaching potential donors, researchers should be aware there may be individual, cultural or religious differences in the meaning and significance attached to the body or specific parts of it. Researchers should aim to achieve an environment of trust and respect with participants. A high level of transparency should be maintained, for example, from seeking consent for the potential future use of samples, to making research results available.

Potential benefits from the research should outweigh any risks to the donors

The physical risks in donating samples for research will usually be minimal, but the risk that information from laboratory tests or linked data of a sample might harm the donor or their interests must not be overlooked.

Maximise the use of samples to benefit science and society.

Wherever possible, researchers should make use of existing resources in an ethical manner with respect and transparency for the donors, rather than collecting new samples. New and existing collections can be made more useful through choice of sample preparation and storage techniques.

Decide whether and how to feedback any health-related findings

Researchers must decide at the outset what their strategy will be regarding feedback of health-related findings to individual donors. Detailed guidance is available in the Wellcome Trust/MRC Framework.

The human body and its parts shall not, as a rule, give rise to direct financial gain

Researchers may not sell for profit samples they have collected as part of UKRI-funded research, and research participants should never be offered any financial inducement to donate samples. Payment of reasonable expenses or costs is acceptable, however.

Information provided to potential donors should be understandable and helpful

When seeking consent, the potential donor (or an appropriate person on their behalf) must be informed and competent to make the decision to participate or not. When obtaining consent, you should consider the value of those samples for future research and, if possible, seek broad and enduring consent to include storage and use for future research.

Patients should be informed when material left over following diagnosis or treatment might be used for research

Samples collected during routine diagnostic procedures are a valuable resource for researchers. They are permitted in law to use diagnostic/pathology archives without consent in certain circumstances.

Research involving human biological material should undergo independent ethical review, with very limited exceptions

This safeguards the rights, safety, dignity and well-being of research participants are ensures, where applicable, that legal requirements in tissue legislation are met5. This review is normally carried out by a Research Ethics Committee (REC) within the NHS or a university.

Researchers should treat as confidential all personal and medical information

The value of human biological material can be maximised by maintaining links with personal or clinical data relating to the donor. People who donate samples for research must be told what personal or medical information about them will be used in the research, who it might be shared with, and what safeguards are protecting their confidentiality.

The ethical and legal principles are detailed in the MRC Ethics Series guidance ‘Using information about people in health research’.

Researchers should keep up to date with all ethical, legislative, regulatory and governance requirements

This includes working with teams and individuals within relevant organisations who have a corporate responsibility to ensure that these requirements are met.

This is the integrated website of the seven research councils, Research England and Innovate UK.
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